Metabolomic Embryo Profiles of Obese in Vitro Fertilization (IVF) Patients and Their Relationship With Polycystic Ovary Syndrome (PCO)

Completed

• Conditions: Infertility; Obesity
• Interventions: Other: Culture medium metabolomic analysis

• Registration Number: NCT01448863
• Lead Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA

Brief Summary

The present study aims to elucidate if there is a metabolomic profile alteration in the embryos of obese women in order to understand if the reduced implantation rate observed in these patients is directly related to this factor. Furthermore, the investigators seek to establish if there is any difference between obese women with Polycystic Ovary Syndrome (PCO) and without PCO. The investigators compare these metabolomic profile embryos with embryos of egg-donation programme.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-05
• Study First Submitted QC: 2011-10-06
• Study First Posted: 2011-10-07
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-09
• Last Update Posted: 2015-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• BMI > 30 kg/m2
• Age < 38 years old
• Non smokers
• First IVF cycle (groups 2 & 3, not Control group)
• Normal uterus (seen by ultrasound)
• normal basal hormonal profile(FSH,LH,estradiol,testosterone,androstenedione, insulin, SHBG, glucose, AMH)
• Antral follicle count(> 5 FA for each ovary)
• Menses every 25-35 days.

Exclusion Criteria

• < 5 or > 20 oocytes retrieved after stimulation cycle
• estradiol >3000 pg/ml or progesterone > 1,5 ng/ml on the hCG day.
• < 2 evolutive embryos in the culture medium.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NO PCO	Culture medium metabolomic analysis	Obese women without Polycystic Ovarian Syndrome
WITH PCO	Culture medium metabolomic analysis	Obese women with Polycystic Ovarian Syndrome
CONTROL	Culture medium metabolomic analysis	Fertile women (egg-donors)

Primary Outcome Measures

Name	Time	Method
Metabolic profile of culture media of Day 3 embryos	3 days	Determine differences in the metabolomic profile of the culture media of day 3 embryos, obtained after in vitro fertilization, according to the presence of obesity associated or not with polycystic ovary syndrome.

Trial Locations

Locations (1)

IVI Valencia; 🇪🇸 Valencia, Spain